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评价两种结合抗体检测试剂盒和中和抗体检测试剂盒在评估 SARS-CoV-2 疫苗接种后的体液免疫应答中的应用。

Evaluation of Humoral Immune Response after SARS-CoV-2 Vaccination Using Two Binding Antibody Assays and a Neutralizing Antibody Assay.

机构信息

Department of Laboratory Medicine, Korea University Anam Hospital, Seoul, South Korea.

Department of Laboratory Medicine, Konkuk Universitygrid.258676.8grid.411120.7grid.258676.8 School of Medicine, Seoul, South Korea.

出版信息

Microbiol Spectr. 2021 Dec 22;9(3):e0120221. doi: 10.1128/Spectrum.01202-21. Epub 2021 Nov 24.

Abstract

Multiple vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed and administered to mitigate the coronavirus disease 2019 (COVID-19) pandemic. We assessed the humoral response of BNT162b2 and ChAdOx1 nCoV-19 using Siemens SARS-CoV-2 IgG (sCOVG; cutoff of ≥1.0 U/ml), Abbott SARS-CoV-2 IgG II Quant (CoV-2 IgG II; cutoff of ≥50.0 AU/ml), and GenScript cPASS SARS-CoV-2 neutralization antibody detection kits (cPASS; cutoff of ≥30% inhibition). We collected 710 serum samples (174 samples after BNT162b2 and 536 samples after ChAdOx1 nCoV-19). Venous blood was obtained 3 weeks after first and second vaccinations. In both vaccines, sCOVG, CoV-2 IgG II, and cPASS showed a high seropositive rate (>95.7%) except for cPASS after the first vaccination with ChAdOx1 nCoV-19 (68.8%). Using sCOVG and CoV-2 IgG II, the ratios of antibody value (second/first) increased 10.6- and 11.4-fold in BNT162b2 (first 14.1, second 134.8 U/ml; first 1,416.2, second 14,326.4 AU/ml) and 2.3- and 2.0-fold in ChAdOx1 nCoV-19 (first 4.0, second 9.1 U/ml; first 431.0, second 9,744.0 AU/ml). cPASS-positive results indicated a very high concordance rate with sCOVG and CoV-2 IgG II (>98%), whereas cPASS-negative results showed a relatively low concordance rate (range of 22.2% to 66.7%). To predict cPASS positivity, we suggested additional cutoffs for sCOVG and CoV-2 IgG II at 2.42 U/ml and 284 AU/ml, respectively. In conclusion, BNT162b2 and ChAdOx1 nCoV-19 evoked robust humoral responses. sCOVG and CoV-2 IgG II showed a very strong correlation with cPASS. sCOVG and CoV-2 IgG II may predict the presence of neutralizing antibodies against SARS-CoV-2. The Siemens severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG (sCOVG; Siemens Healthcare Diagnostics Inc., NY, USA) and Abbott SARS-CoV-2 IgG II Quant (CoV-2 IgG II; Abbott Laboratories, Sligo, Ireland), which are automated, quantitative SARS-CoV-2-binding antibody assays, have been recently launched. This study aimed to evaluate the humoral immune response of BNT162b2 and ChAdOx1 nCoV-19 vaccines using sCOVG and CoV-2 IgG II and compare the quantitative values with the results of the GenScript surrogate virus neutralization test (cPASS; GenScript, USA Inc., NJ, USA). Our findings demonstrated that both BNT162b2 and ChAdOx1 nCoV-19 elicited a robust humoral response after the first vaccination and further increased after the second vaccination. sCOVG and CoV-2 IgG II showed a strong correlation, and the concordance rates among sCOVG, CoV-2 IgG II, and cPASS were very high in the cPASS-positive results. The additional cutoff sCOVG and CoV-2 IgG II could predict the results of cPASS.

摘要

多种针对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的疫苗已被开发并用于减轻 2019 年冠状病毒病 (COVID-19) 大流行。我们使用西门子 SARS-CoV-2 IgG (sCOVG;cutoff≥1.0 U/ml)、雅培 SARS-CoV-2 IgG II Quant (CoV-2 IgG II;cutoff≥50.0 AU/ml) 和 GenScript cPASS SARS-CoV-2 中和抗体检测试剂盒 (cPASS;cutoff≥30%抑制) 评估了 BNT162b2 和 ChAdOx1 nCoV-19 的体液反应。我们收集了 710 份血清样本(174 份 BNT162b2 后和 536 份 ChAdOx1 nCoV-19 后)。静脉血在第一次和第二次接种后 3 周采集。在这两种疫苗中,sCOVG、CoV-2 IgG II 和 cPASS 显示出高血清阳性率(>95.7%),除了 ChAdOx1 nCoV-19 的第一次接种后 cPASS(68.8%)。使用 sCOVG 和 CoV-2 IgG II,BNT162b2 的抗体值(第二次/第一次)比值增加了 10.6 倍和 11.4 倍(第一次 14.1,第二次 134.8 U/ml;第一次 1416.2,第二次 14326.4 AU/ml)和 ChAdOx1 nCoV-19 的 2.3 倍和 2.0 倍(第一次 4.0,第二次 9.1 U/ml;第一次 431.0,第二次 9744.0 AU/ml)。cPASS 阳性结果与 sCOVG 和 CoV-2 IgG II 具有非常高的一致性率(>98%),而 cPASS 阴性结果显示出相对较低的一致性率(范围为 22.2%至 66.7%)。为了预测 cPASS 阳性,我们建议分别将 sCOVG 和 CoV-2 IgG II 的截止值提高到 2.42 U/ml 和 284 AU/ml。总之,BNT162b2 和 ChAdOx1 nCoV-19 引起了强烈的体液反应。sCOVG 和 CoV-2 IgG II 与 cPASS 具有很强的相关性。sCOVG 和 CoV-2 IgG II 可能预测 SARS-CoV-2 中和抗体的存在。西门子严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) IgG (sCOVG;西门子医疗诊断公司,纽约,美国) 和雅培 SARS-CoV-2 IgG II Quant (CoV-2 IgG II;雅培实验室,爱尔兰斯莱戈),这两种是最近推出的自动化、定量 SARS-CoV-2 结合抗体检测试剂盒。本研究旨在使用 sCOVG 和 CoV-2 IgG II 评估 BNT162b2 和 ChAdOx1 nCoV-19 疫苗的体液免疫反应,并比较定量值与 GenScript 替代病毒中和试验 (cPASS;GenScript,美国新泽西州) 的结果。我们的研究结果表明,BNT162b2 和 ChAdOx1 nCoV-19 在第一次接种后均引起了强烈的体液反应,第二次接种后进一步增加。sCOVG 和 CoV-2 IgG II 显示出很强的相关性,并且在 cPASS 阳性结果中,sCOVG、CoV-2 IgG II 和 cPASS 之间的一致性率非常高。额外的截止值 sCOVG 和 CoV-2 IgG II 可以预测 cPASS 的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/495d/8612149/37eb28508fcc/spectrum.01202-21-f001.jpg

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